GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT351418Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00733132618491), received between Aug 6, 2018 and Oct 17, 2025 — classified as 2 deaths, 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (8 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2013, THE PATIENT WAS TREATED USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT) DUE TO UNKNOWN CONDITION. ON (B)(6) 2025, DURING FOLLOW-UP IMAGING, A TYPE 1A ENDOLEAK WAS OBSERVED. REINTERVENTION IS PLANNED FOR A LATER DATE (NOT SCHEDULED YET). THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Clinical Endoleak

  MAUDE report 23323064 ↗
• InjurySep 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FSA REPORTED THE FOLLOWING TO GORE: ON (B)(6) 2024, THE PATIENT PRESENTED WITH APPEARED TO BE A TYPE 1A ENDOLEAK. THE FSA RECEIVED IMAGES TO REVIEW FOR A TAMBE CASE AND NOTICED A LEAK. A REINTERVENTION IS BEING PLANNED ALTHOUGH THERE IS NOT A SCHEDULED DATE AS OF NOW.

  Patient problems: Clinical Endoleak

  MAUDE report 20170419 ↗
• InjuryAug 22, 2024Migration; Migration

  THE FOLLOWING WAS REPORTING TO GORE: ON (B)(6) 2024, A PATIENT HAD A REINTERVENTION DUE TO MIGRATION LEADING TO ENDOLEAK OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PHYSICIAN PLACED A PHYSICIAN-MODIFIED STENT GRAFT PROXIMALLY, WITH FENESTRATIONS FOR THE SMA, CELIAC, AND RENAL ARTERIES. THE REINTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED. REPORTEDLY, THE MIGRATION WAS GREATER THAN 7CM.

  Patient problems: Aneurysm expansion; Clinical Endoleak; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029308 ↗
• InjuryMar 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED THREE GORE® EXCLUDER® AAA ENDOPROSTHESES, (RLT351418, PXL161407, PXC121200). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, THE FSA WAS INFORMED THAT THERE WAS A TYPE I ENDOLEAK, AND THAT A REINTERVENTION WAS PLANNED TO ADD A PROXIMAL CUFF. ON (B)(6) 2024, A REINTERVENTION WAS PERFORMED. THE PHYSICIAN IMPLANTED A CUFF AND ANCHORS. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18969946 ↗
• InjuryMar 8, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2014, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3, CONTRALATERAL LEG AND ILIAC EXTENDER). ON (B)(6) 2024, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED THAT THE PHYSICIAN PLANS TO BRING IN THE PATIENT FOR A POSSIBLE REINTERVENTION (DATE NOT PLANNED YET) DUE TO A PROXIMAL TYPE 1 ENDOLEAK AND ANEURYSM GROWTH OF 8.5CM ON GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3). REPORTEDLY, PHYSICIAN PLANS TO TREAT THE PROXIMAL TYPE 1 ENDOLEAK BY PROXIMAL EXTENSION WITH AN AORTIC EXTENDER. ADDITIONAL INFORMATION CAME IN ON APRIL 22, 2024 THAT A REINTERVENTION DID OCCUR ON (B)(6) 2024 TO TREAT THE ENDOLEAK. PHYSICIAN ADDED AN AORTIC EXTENDER TO EXTEND PROXIMALLY. ENDOLEAK WAS RESOLVED AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18870183 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR A PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN). THE PROXIMAL TRUNK WAS EXTENDED WITH TWO GORE® EXCLUDER® AORTIC EXTENDER COMPONENTS. THE PHYSICIAN REPORTED NO ENDOLEAK WAS SEEN; BUT DUE TO ANEURYSM ENLARGEMENT AND SOME LACK OF APPOSITION OF THE PROXIMAL TRUNK HE CHOSE TO EXTEND. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 17438702 ↗
• InjuryJul 17, 2023Patient-Device Incompatibility; Migration; Patient-Device Incompatibility; Migration

  ON (B)(6) 2019, PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS AND A CONTRALATERAL LEG ENDOPROSTHESIS. ON (B)(6) 2023, PATIENT PRESENTED WITH A MIGRATED EXCLUDER GRAFT THAT WAS NOW LOCATED APPROXIMATELY 3-4CM BELOW THE RENAL ARTERIES. THE PHYSICIAN ATTRIBUTED THIS MIGRATION, DUE TO DISEASE PROGRESSION WITH INFRARENAL AORTIC NECK. NO ENDOLEAK APPEARED PRESENT AND THERE WAS MINIMAL TO NO SAC GROWTH ACCORDING TO PHYSICIAN. ON (B)(6) 2023, AN ANGIOGRAM WAS PERFORMED WHICH SHOWED A FAINT(SLIGHT) TYPE 1A ENDOLEAK WHICH THE PHYSICIAN DECIDED TO TREAT. REINTERVENTION SURGERY WAS PERFORMED, AND TREATMENT WAS MADE BY EXTENDING THE PROXIMAL SEAL ZONE TO THE RENAL ARTERIES, IMPLANTING 2 CONFORMABLE AORTIC EXTENDERS (CXA36005 L/S#26618240; CXA36005 L/S#: 26614093), AND 1 AORTIC EXTENDER (PLA360400 L/S#:24897293). THE TYPE 1A WAS RESOLVED AT THE COMPLETION OF THE CASE. PATIENT TOLERATED THE PROCEDURE WELL AND IS DOING FINE. IT WAS LATER REPORTED THAT THE LEAK WAS ONLY OBSERVED IN THE RLT351418 DEVICE AND ONLY THE RLT351418 DEVICE MIGRATED.

  Patient problems: Clinical Endoleak

  MAUDE report 17336872 ↗
• InjuryJun 8, 2023Migration; Migration

  THE PATIENT PRESENTED WITH AN INFRARENAL AORTIC ANEURYSM AND WAS TREATED ON (B)(6) 2015 USING THE GORE EXCLUDER WITH C3 DELIVERY SYSTEM AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN COMPLETED AN ANGIOGRAM ON (B)(6) 2021 TO ATTEMPT TO IDENTIFY A POSSIBLE ENDOLEAK (TYPE 1A OR TYPE 2) ON PATIENT. THE PHYSICIAN BELIEVED A TYPE 1A ENDOLEAK WAS PRESENT AND DECIDED TO TREAT. THE PHYSICIAN HAD DONE A SECOND PROCEDURE USING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE AORTIC EXTENSION CUFFS WERE PLACED SUCCESSFULLY, AND THE PATIENT TOLERATED THE PROCEDURE WELL. SEE CASE (B)(6). THE PATIENT PRESENTED ON (B)(6) 2023 WITH AN EXPANDING ANEURYSM (>1CM IN GROWTH SINCE 2021) AND A PROXIMAL TYPE 1A ENDOLEAK. DUE TO ADDITIONAL DISEASE IN THE PROXIMAL NECK, AND SOME NECK ANGULATION, THE SEAL IN THE PROXIMAL NECK WAS LOST AND ORIGINAL SYSTEM HAD APPEARED TO DROP APPROXIMATELY 3CM. THREE GORE® EXCLUDER® AAA ENDOPROSTHESS WERE PLACED AS PROXIMAL EXTENSIONS FROM THE TOP OF THE CURRENT SYSTEM AND EXTENDED TO THE RENALS. SEAL WAS ATTAINED IN THE PROXIMAL NECK FOLLOWING PLACEMENT OF THESE CUFFS. PATIENT TOLERATED THE PROCEDURE WELL AND IS REPORTED TO BE DOING

  Patient problems: Clinical Endoleak

  MAUDE report 17087108 ↗
• InjuryApr 26, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). ON FOLLOW UP DATE OF (B)(6) 2023 (CT SCAN), REPORTEDLY, THE PATIENT CAME IN DURING A ROUTINE VISIT FOR AN ANEURYSM (SIZE UNKNOWN) AND NOT THE ACTUAL FOLLOW UP OF INITIAL IMPLANT, WHERE, THE PHYSICIAN NOTICED THAT THERE WAS NECK DILATION WITH HIGH NECK ANGLE THAT HAD LOST THE GRAFT SEAL APPOSITION ON THE PROXIMAL END OF THE EXCLUDER GRAFT AND THE GRAFT DROPPED INTO THE ANEURYSM SAC MIGRATING DISTALLY (MIGRATION DISTANCE UNKNOWN) AND THE PHYSICIAN DECIDED TO INTERVENE. ON (B)(6) 2023, THE PATIENT UNDERWENT A ZONE 9-INFRARENAL REINTERVENTION UTILIZING TWO GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM. THE DEVICES WERE IMPLANTED FROM THE RENAL ARTERIES DOWN TO THE EXISTING ENDOGRAFT AS THE EXCLUDER DEVICE WOULD NOT STAY IN PLACE DUE TO THE PATIENT'S AORTA DIAMETER BEING LARGE, HENCE, THE PHYSICIAN OPTED TO USE THE TAG DEVICES. THE PATIENT TOLERATED THE PROCEDURE. IMAGING EVALUATION SUMMARY: THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWIN

  Patient problems: Aneurysm expansion

  MAUDE report 16818416 ↗
• InjuryJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE GORE CLINICAL SPECIALIST (CS) REPORTED THE FOLLOWING: ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND A ¿DILATED LEFT COMMON ILIAC ARTERY IN AN OFF-LABEL FASHION¿. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT RECENT FOLLOW UP IMAGES (DATE IS UNKNOWN) REVEALED THE LEFT COMMON ILIAC ARTERY HAS SINCE DILATED TO 62 MM (ORIGINAL DIAMETER IS UNKNOWN) IN MAXIMUM DIAMETER. A DISTAL TYPE I ENDOLEAK WITH LACK OF WALL APPOSITION WAS REVEALED. IT IS UNKNOWN WHICH IMPLANTED DEVICE HAD THE ENDOLEAK. ON (B)(6) 2022, THE PHYSICIAN REINTERVENED AND IMPLANTED A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES ¿SYSTEM WITH BRIDGING INTO THE PRIOR LEFT SIDED LIMB." THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 16162585 ↗
• InjuryOct 29, 2022Migration; Migration

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022, THE PHYSICIAN MADE THE GORE REPRESENTATIVE AWARE THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS REPORTEDLY SITTING FURTHER BELOW THE RENAL ARTERIES THAN WAS EXPECTED (DISTANCE UNKNOWN). THE PHYSICIAN REPORTED THAT IT WAS UNKNOWN IF THE DEVICE HAD MIGRATED, IF THERE WAS ANEURYSM ENLARGEMENT, OR IF THERE WAS ANOTHER CAUSE FOR THE DEVICE BEING MORE DISTAL THAN EXPECTED. A REINTERVENTION WILL BE PERFORMED AT A LATER DATE TO PLACE A GORE® EXCLUDER® AAA AORTIC EXTENDER COMPONENT. THE REINTERVENTION HAS NOT YET BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697251 ↗
• InjuryMay 20, 2022Migration; Migration

  ON AN UNSPECIFIED DATE THE PATIENT PRESENTED WITH ABDOMINAL/GROIN PAIN. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS PERFORMED AND REVEALED MIGRATION OF A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT351418), AND A PROXIMAL TYPE 1 ENDOLEAK. AS REPORTED, THE PREVIOUSLY IMPLANTED RLT RLT351418 HAD MIGRATED 9.5 CENTIMETERS AND THE IDENTIFIED CAUSE WAS ONGOING DISEASE PROGRESSION WITH AORTIC NECK DILATION. THE ANEURYSM WAS OBSERVED TO HAVE GROWN APPROXIMATELY 8 CENTIMETERS IN DIAMETER. ON (B)(6) 2022 A REINTERVENTION WAS PERFORMED. THE PHYSICIAN ELECTED TO USE A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAG AC, CATALOG#: TGMR404010) TO CONTAIN A RUPTURE OF THE ANEURYSM. AS REPORTED, THE CTAG AG WAS USED IN AN UNSPECIFIED OFF-LABEL MANNER. REPORTEDLY, THE TYPE I ENDOLEAK WAS CONTAINED. THE PATIENT WAS OBSERVED TO BE DOING WELL. THE PHYSICIAN DOES NOT REQUIRE ANY FOLLOW-UP ON THIS CASE. NO IMAGES ARE AVAILABLE FOR CONSIDERATION.

  Patient problems: Aneurysm

  MAUDE report 14453367 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING: ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES (MODALITY AND DATE IS UNKNOWN), REVEALED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN IF THERE IS ANEURYSM SAC ENLARGEMENT. REPORTEDLY, DURING THE INITIAL PROCEDURE THE GORE® EXCLUDER® TRUNK IPSILATERAL LEG ENDOPROSTHESIS WAS INTENTIONALLY DEPLOYED LOWER DISTALLY TO THE RENAL ARTERIES DUE TO A REVERSE TAPERED AORTIC NECK. THERE WAS A REINTERVENTION ON (B)(6) 2022. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES AORTIC EXTENDER IN THE PROXIMAL SEAL ZONE FROM THE ORIGINAL PROCEDURE. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 14189913 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE (FSA) REPORTED: ON (B)(6) 2015, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY DURING THIS PROCEDURE, THE PHYSICIAN TAPERED DOWN THE IMPLANTED GRAFTS 32MM FROM THE RENAL ARTERIES TO 24MM DISTALLY. THE PHYSICIAN HAD IMPLANTED A COOK CUFF STENT PROXIMAL OF THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT WAS ADMITTED EMERGENTLY. A TYPE III ENDOLEAK WAS REVEALED (SEPARATION BETWEEN THE COOK STENT AND THE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS) AND ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT TO RELINE 8CM OF LENGTH, FROM THE LOWEST RENAL ARTERY TO THE FLOW DIVIDER OF THE IMPLANTED TRUNK-IPSILATERAL LEG ENDOPROSTHESIS. THE PATIENT TOLERATED THE REINTERVENTION.

  MAUDE report 13765641 ↗
• InjuryDec 28, 2021Migration; Migration

  ON (B)(6) 2013 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS STENT GRAFT IPSILATERAL LEG COMPONENT C3 ((B)(4)). ON (B)(6) 2021 IT WAS REPORTED THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS STENT GRAFT IPSILATERAL LEG COMPONENT C3 ((B)(4)) HAD MIGRATED TO ABOUT 35MM DISTAL OF THE RENAL ARTERIES. REINTERVENTION WAS SCHEDULED FOR (B)(6) 2021. ON (B)(6) 2021 THE FSA CONFIRMED THAT IT HAD OCCURRED. THE PHYSICIAN ELECTED TO USE A COOK TEVAR GRAFT FOR THE MIGRATION REPAIR. THE PROCEDURE WENT WELL. THERE WERE NO INCIDENTS NOTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13102229 ↗
• InjurySep 29, 2021Partial Blockage; Partial Blockage

  THE CLINICAL SPECIALIST (CS) REPORTED: ON (B)(6) 2020, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT IMAGES REVEALED ¿IT APPEARS THAT THE IPSILATERAL LIMB OF THE GRAFT IS TWISTED AND RESTRICTING FLOW". THE PATIENT IS ASYMPTOMATIC. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. THE CS REPORTED THAT AN ADDITIONAL 11MMX59MM GRAFT WAS IMPLANTED INSIDE WHERE THE STENOSIS/TWIST OF THE PREVIOUSLY IMPLANTED GRAFT WAS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12549993 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021 A PERSISTENT TYPE II ENDOLEAK, WHICH WAS FIRST DISCOVERED ON (B)(6) 2017, WAS SEEN ON FOLLOW UP. ON (B)(6)2021, THE PATIENT UNDERWENT REPAIR OF THE TYPE II ENDOLEAK VIA ONYX EMBOLIZATION OF THE PROXIMAL CELIAC ARTERY. THE PATIENT WAS DISCHARGED ON (B)(6) 2021.

  Patient problems: Aneurysm

  MAUDE report 11813123 ↗
• InjuryMar 25, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THE PATIENT UNDERWENT REINTERVENTION FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH A MAXIMUM DIAMETER MEASURING 65.0MM. TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO RELINE AN UNKNOWN MANUFACTURER¿S ENDOVASCULAR DEVICES PREVIOUSLY IMPLANTED ON AN UNKNOWN DATE IN 2010 FOR TREATMENT OF A AAA. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME ON (B)(6) 2015. THE PATIENT UNDERWENT INTERVENTION OF TYPE II ENDOLEAKS AND SUBSEQUENT ANEURYSM ENLARGEMENT ON (B)(6) 2015, (B)(6) 2018, AND (B)(6) 2019. AT THE TIME OF THE LAST INTERVENTION, THE ANEURYSM MEASURED 96.0MM. ON (B)(6) 2019, AN ARTERIOGRAM WAS PERFORMED. ON (B)(6) 2019, THE ANEURYSM MEASURED 92.0MM. ON (B)(6) 2020, THE ANEURYSM MEASURED 91.0MM. ON (B)(6) 2021, THE ANEURYSM MEASURED 99.0MM. ON (B)(6) 2021 A TYPE II ENDOLEAK WAS IDENTIFIED. IT WAS NOTED THAT, DUE TO CONCERNING GROWTH OF THE AAA AND TO THE ENDOLEAK BEING OBSERVED AGAIN AT THE LEVEL OF THE L3 VERTEBRAL BODY, SURGERY OF SELECTIVE BRANCH VESSELS IS SCHEDULED FOR (B)(6) 2021.

  Patient problems: Aneurysm

  MAUDE report 11570133 ↗
• InjuryMar 12, 2021Malposition of Device; Malposition of Device

  IN PREPARATION FOR A PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM, A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM, RLT351414 WAS PREPARED BY THE SCRUB TECH. WHILE REMOVING THE MANDREL, THE TECH TORE A GLOVE, CONTAMINATING THE DEVICE. DUE TO SEVERE WEATHER, ANOTHER RLT351414 WAS UNAVAILABLE, AND A RLT351418 WAS USED FOR THE PROCEDURE. DOING SO RESULTED IN A COVERED HYPOGASTRIC, WHICH WAS COILED. THE PATIENT TOLERATED THE PROCEDURE. THE RLT351414 WAS DISCARDED AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474040 ↗
• MalfunctionFeb 16, 2021Difficult to Advance; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICES FOR INSERTION WERE PREPPED AS INSTRUCTED PER IFU. A GORE® DRYSEAL FLEX SHEATH WAS ADVANCED AND PLACED JUXTA RENALLY. WHILE ADVANCING THE TRUNK-IPSILATERAL LEG COMPONENT OVER A 0.035" WIRE WITH A BACK UP MEIER WIRE (BOSTON SCIENTIFIC), A LITTLE RESISTANCE WAS FELT DURING ADVANCEMENT OF THE DEVICE BUT ADVANCEMENT TO THE RENALS WAS ACCOMPLISHED. WHILE MANIPULATING, THE SHEATH AND DEVICE SLIPPED INTO THE AAA SAC. FORWARD PRESSURE WAS APPLIED TO THE DEVICE, BUT THE DEVICE DIDN'T MOVE FORWARD AS MUCH AS EXPECTED AND RESISTANCE WAS HIGH. A PLAN WAS MADE TO WITHDRAW THE DEVICE, INSERT THE DILATOR AND ADVANCE THE SHEATH AGAIN ABOVE THE RENALS IN ORDER TO FACILITATE THE DEVICE POSITIONING, BUT IT WAS NOT POSSIBLE TO MOVE THE DEVICE FORWARD OR BACK. WHILE TRYING TO MANIPULATE, THE RESISTANCE INCREASED AND THE DEVICE BECAME STUCK. HAVING ANOTHER DEVICE AVAILABLE, IT WAS DECIDED TO REMOVE THE WHOLE SYSTEM WITH THE WIRE TOGETHER IN TANDEM. AFTER THE SYSTEM AND WIRE WERE REMOVED FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11335309 ↗
• DeathFeb 8, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR REINTERVENTION FOR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK ASSOCIATED WITH A PREVIOUSLY IMPLANTED ENDOLOGIX ABDOMINAL STENT GRAFT SYSTEM. A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT WAS IMPLANTED TO RELINE THE ENDOLOGIX GRAFT. IT WAS REPORTED THAT THE TRUNK IPSILATERAL LEG COMPONENT HAD BEEN DEPLOYED TOO FAR PROXIMAL, LANDING BEHIND THE TOP END OF THE ENDOLOGIX GRAFT LEAVING A SEPARATION AND A TYPE III ENDOLEAK. THE PATIENT WAS COVERTED TO OPEN REPAIR AND THE GRAFTS WERE EXPLANTED. DURING THE CONVERSION, IT WAS REPORTED THAT THE PATIENT ENDURED AN AORTIC RUPTURE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT PATIENT EXPIRED. THE CAUSE OF DEATH WAS THOUGHT TO BE DUE TO THE AORTIC RUPTURE.

  Patient problems: Rupture

  MAUDE report 11298056 ↗
• InjuryDec 14, 2020Migration; Migration

  ON (B)(6) 2020 THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2020, GORE BECAME AWARE THAT THE DEVICE HAD MIGRATED DISTALLY. ON (B)(6) 2020, A REINTERVENTION OCCURRED TO TREAT THE MIGRATION. DETAILS CONCERNING THE TREATMENT HAS NOT BEEN REPORTED TO GORE.

  Patient problems: Aneurysm

  MAUDE report 11003453 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 74 MM. THE PATIENT'S INFRARENAL NECK ANGLE MEASURED 16 DEGREES. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2015 SHOWED THE ANEURYSM MEASURED 74 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2016 SHOWED THE ANEURYSM MEASURED 74 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2017 SHOWED THE ANEURYSM MEASURED 82MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2017 SHOWED THE ANEURYSM MEASURED 79 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 84 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 88 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 85 MM. FOLLOW UP COMPUTED TOM

  Patient problems: Aneurysm

  MAUDE report 10885320 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015 THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 74 MM. THE PATIENT'S INFRARENAL NECK ANGLE MEASURED 16 DEGREES. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2015 SHOWED THE ANEURYSM MEASURED 74 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2016 SHOWED THE ANEURYSM MEASURED 74 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2017 SHOWED THE ANEURYSM MEASURED 82MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2017 SHOWED THE ANEURYSM MEASURED 79 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 84 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 88 MM. FOLLOW UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) EXAMINATION ON (B)(6) 2018 SHOWED THE ANEURYSM MEASURED 85 MM. FOLLOW UP COMPUTED TOM

  Patient problems: Aneurysm

  MAUDE report 10885154 ↗
• InjuryNov 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DEPLOYMENT SYSTEM. ON (B)(6) 2019, A TYPE II ENDOLEAK WAS IDENTIFIED. ON THE SAME DAY, THE ENDOLEAK WAS TREATED WITH EMBOLIZATION WITH ONYX COILS. THE PATIENT REFERENCED IN THIS EVENT FILE IS ENROLLED IN A POST-MARKET PROSPECTIVE OBSERVATIONAL COHORT REGISTRY DESIGNED TO OBTAIN DATA ON DEVICE PERFORMANCE AND CLINICAL OUTCOMES OF PATIENTS TREATED WITH GORE ENDOVASCULAR AORTIC PRODUCTS THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT). MEDIDATA RAVE® IS THE CLINICAL STUDY DATABASE (CSD), CAPTURING THE DATA THROUGH THE GRT 10-11 MODULE. THE ABOVE INFORMATION WAS OBTAINED FROM THE CSD.

  Patient problems: Aneurysm

  MAUDE report 10860843 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis